Comparison of the Efficacy of ultrasound guided injection of Corticosteroid, Platelet-rich Plasma(PRP), and Ozone on pain and function of patients with lateral epicondylitis: A multicenter randomized clinical trial
comparing the efficacy of us-guided injection of corticosteroid, PRP, and ozone on pain and function of patients with lateral epicondylitis
Design
A controlled, parallel-group, double-blind, randomized,clinical trial on 90 patients
Settings and conduct
Blindness: patients, interventionist, outcome assessor, statistician and the researcher
US guided injection of 90 patients with tennis elbow randomly assigned into 3 groups of 30(steroid,PRP and ozone)
Follow up 2 and 6 months after injection
Place of study: Modares hospital and Modava pain clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria:
treatment-resistant tennis elbow
duration of 3 months or more
pain intensity of VAS 5 or more
age of 20 to 50 years
/
Exclusion criteria:
Symptoms of an infectious disease or fever in the last few days
Thyroid dysfunction or uncontrolled diabetes
Rheumatic disease
History of blood or bone malignancy
Elbow joint injury
Carpal tunnel syndrome and other peripheral nerve injuries
Cervical radiculopathy
Hx of autoimmune disease
Platelet dysfunction
Treatment with antiplatelet drugs in the last 10 days
Platelets<150,000
Treatment with NSAID within 48 hours before injection
Steroid use in the past 3 weeks
Hb<10
Pregnancy or breastfeeding
Treatment of tennis elbow with steroids in the last 6 months
Lateral epicondylitis surgery
Ozone sensitivity
G6PD
Taking ACE inhibitor
Intervention groups
1. 30 patients :40 mg of methylprednisolone acetate in a volume of 1 ml
2. 30 patients: 3 cc of platelets with a concentration of 4-6 times that of blood platelets resulting from two rounds of centrifugation containing leukocyte poor plasma without adding activators.
3. 30 patients:10 ml of ozone with a concentration of 15 micrograms per ml
Main outcome variables
lateral epicondyle pain/ patient's daily living performance /Pain pressure threshold
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130523013442N35
Registration date:2023-11-19, 1402/08/28
Registration timing:registered_while_recruiting
Last update:2023-11-19, 1402/08/28
Update count:0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of ultrasound guided injection of Corticosteroid, Platelet-rich Plasma(PRP), and Ozone on pain and function of patients with lateral epicondylitis: A multicenter randomized clinical trial
Public title
Comparison of the Efficacy of ultrasound guided injection of Corticosteroid, Platelet-rich Plasma(PRP), and Ozone on pain and function of patients with lateral epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with treatment-resistant tennis elbow
duration of 3 months or more
pain intensity of VAS 5 or more
age of 20 to 50 years
Exclusion criteria:
Symptoms of an infectious disease or fever in the last few days
Thyroid dysfunction or uncontrolled diabetes
Rheumatic disease
History of hematologic or bone malignancy
Elbow joint injury
Carpal tunnel syndrome and other peripheral nerve injuries including radial nerve injury
Cervical radiculopathy that affects the Mayo questionnaire
History of autoimmune disease
Platelet disorder
Treatment with antiplatelet drugs in the last 10 days
Platelets below 150,000
Treatment with non-steroidal anti-inflammatory drugs within 48 hours before injection
Steroid use in the past 3 weeks
Hemoglobin below 10
History of vasovagal shock
Pregnancy or breastfeeding
Treatment of lateral epicondylitis with steroids in the last 6 months
Lateral epicondylitis surgery
Ozone sensitivity
G6PD
Taking ACE inhibitor
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
in this clinical trial study, 90 patients with a diagnosis of lateral epicondylitis will be included in the study randomly .For random allocation of individuals in the study groups (intervention or intervention group and comparison or comparison group), the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1: 1 will be used. Random Allocation software 2.0 will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified with two type of cards which are including group a (1st intervention group), b (2nd intervention group) and c (control group) and these cards are placed inside the sealed envelopes in order .In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined. Due to the multicenter nature of this study, the randomization of the study subjects will be performed separately in each center.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, all patients, caregivers, responsible for data collection, examiner are all unaware of the intervention performed for included participants. To blind the examiner, the injection syringes will be covered. Patients will be randomly assigned to the intervention groups and will not be aware of the injected substance used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-02-22, 1401/12/03
Ethics committee reference number
IR.SBMU.MSP.REC.1401.645
Health conditions studied
1
Description of health condition studied
lateral epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis
Primary outcomes
1
Description
pain in lateral epicondyle
Timepoint
At the beginning of the study (before the start of the intervention) and 2 months and 6 months after the intervention
Method of measurement
Visual analogue scale (VAS)
2
Description
pain pressure thresold
Timepoint
At the beginning of the study (before the start of the intervention) and 2 months and 6 months after the intervention
Method of measurement
Algometer
3
Description
patient's performance
Timepoint
At the beginning of the study (before the start of the intervention) and 2 months and 6 months after the intervention
Method of measurement
Mayo questionnaire score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients with lateral epicondylitis who are injected with 10 ml of ozone with a concentration of 15 μg/ml under ultrasound guidance.
Category
Treatment - Drugs
2
Description
Intervention group: 30 patients with lateral epicondylitis who are injected with 3 cc of platelets under ultrasound guidance. with a concentration of 4-6 times that of blood platelets resulting from two rounds of centrifugation (first 12 minutes at 1600 rpm and the next round at 7 minutes at 3500 rpm) containing leukocyte poor plasma without adding activators
Category
Treatment - Drugs
3
Description
Control group: 30 patients with lateral epicondylitis who are injected with 40 mg of methylprednisolone acetate in a volume of 1 ml under ultrasound guidance.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mosarres Hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Shahid Modarres hospital , Kaj Square, Sa'adat abad
Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
a_raeissadat@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahfam pourazin
Position
Resident of Physical medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
mahfampourazin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
a_raeissadat@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahfam Pourazin
Position
resident of Physical medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
terhan
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
mahfampourazin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the data of people participating in this study can be shared after deidentifying people
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
Data of this study will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers.
From where data/document is obtainable
By sending an email to mahfampourazin@gmail.com
What processes are involved for a request to access data/document
Sending an e-mail and explaining the purpose and how to use the data